Acetylsalicylic Acid Angeneric 500 mg 20 Tablets

Therapeutic indications

Symptomatic therapy of feverish states and flu and cold syndromes. Symptomatic treatment of headache, toothache, neuralgia, menstrual pain, rheumatic and muscular pain.

Dosage

1–2 tablets 2–3 times a day. The tablets should always be taken with water, tea, lemonade, etc. The use of the medicinal product is reserved for adult patients only. Always use the lowest effective dosage and only increase it if it is not sufficient to relieve symptoms (pain and fever). Do not exceed the recommended doses: in particular, elderly patients should follow the minimum dosages indicated above. Those most at risk of serious side effects, who can use the drug only if prescribed by a doctor, must strictly follow its instructions (see section 4.4). Use the medicine for the shortest period possible. Do not take the product for more than 3–5 days without medical advice. See your doctor if symptoms persist. Take the medicine preferably after main meals or in any case on a full stomach.

Overdose

Salicylate toxicity (a dose greater than 100 mg / kg / day for 2 consecutive days can induce toxicity) may be the consequence of chronic overdose, or acute overdose, which is potentially life-threatening and also includes accidental ingestion in children. Chronic salicylate poisoning can be insidious since the signs and symptoms are nonspecific. Mild chronic salicylate poisoning, or salicism, usually occurs only after repeated use of large doses. Symptoms include dizziness, vertigo, tinnitus, deafness, sweating, nausea and vomiting, headache and confusion. These symptoms can be controlled by reducing the dosage. Tinnitus can occur at plasma concentrations between 150 and 300 mcg / ml, while more serious adverse events occur at concentrations above 300 mcg / ml. The main characteristic of acute intoxication is a severe alteration of the acid-base balance, which can vary with age and the severity of the intoxication; the most common presentation in the child is metabolic acidosis. It is not possible to estimate the severity of poisoning from plasma concentration alone; Absorption of acetylsalicylic acid may be delayed due to reduced gastrointestinal emptying, the formation of concrements in the stomach, or as a result of the ingestion of gastrointestinal preparations. Management of acetylsalicylic acid intoxication is determined by the extent, stage and clinical symptoms of the latter, and must be implemented according to conventional poisoning management techniques. The main measures to be taken consist in accelerating drug excretion and restoring electrolyte and acid-base metabolism. Due to the complex pathophysiological effects associated with salicylate poisoning, the signs and symptoms / results of biochemical and instrumental investigations may include:

Signs and symptoms	Results of biochemical and instrumental investigations	Therapeutic measures
Mild to moderate poisoning		Gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis
Tachypnea, hyperventilation, respiratory alkalosis	Alkalemia, lacaluria	Fluid and electrolyte management
Sweating
Nausea, vomiting, headache, dizziness
MODERATE TO SEVERE POISONING		Gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis, hemodialysis in severe cases
Respiratory alkalosis with compensatory metabolic acidosis	Acidemia, aciduria	Fluid and electrolyte management
Hyperpyrexia		Fluid and electrolyte management
Respiratory: variable from hyperventilation non-cariogenic pulmonary edema to respiratory arrest and asphyxiation
Cardiovascular: variable from arrhythmias and hypotension to cardiac arrest
Loss of fluids and electrolytes: dehydration, from oliguria to kidney failure	Eg. hypokalaemia, hypernatremia, hyponatremia, impaired renal function	Fluid and electrolyte management
Alterations in glucose metabolism, ketosis	Hyperglycaemia, hypoglycaemia (especially in children) Increased ketone levels
Tinnitus, deafness
Gastrointestinal: gastrointestinal bleeding, gastric ulcer
Hematological: coagulopathy, iron deficiency anemia	Eg. PT prolongation, hypoprothrombinemia
Neurological: toxic encephalopathy and CNS depression with manifestations ranging from lethargy and confusion to coma and convulsions. Cerebral edema.
Hepatic: liver damage	Increased levels of liver enzymes

At high dosages can also appear: alterations in taste. Skin rashes (acneiform, erythematous, scarlet form, eczematoid, desquamative, bullous, purpuric), itching. Others: conjunctivitis, anorexia, decreased visual acuity, drowsiness. Rarely: aplastic anemia, agranulocytosis, disseminated intravascular coagulation, pan cytopenia, leukopenia, thrombocytopenia, eosinopenia, purpura, eosinophilia associated with drug induced hepatotoxicity, nephrotoxicity (allergic tubular-interstitial nephritis), hematuria. Acute allergic reactions following the intake of acetylsalicylic acid can be treated, if necessary, with the administration of adrenaline, corticosteroids and an antihistamine. In the event of an overdose, the patient should be advised to contact a poison control center immediately or to the nearest hospital. Acetylsalicylic acid is dialyzable.

Contraindications

Acetylsalicylic acid Angeneric tablets are contraindicated in case of: - hypersensitivity to the active substance (acetylsalicylic acid), to other analgesics (pain relievers) / antipyretics (antipyretics) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients; - Gastroduodenal ulcer; - Hemorrhagic diathesis; - Severe renal, cardiac or hepatic insufficiency; - Deficit of glucose – 6 – phosphate dehydrogenase (G6PD / favism); - Concomitant treatment with methotrexate (at doses of 15 mg / week or more) or with warfarin (see section 4.5); - History of asthma induced by administration of salicylates or substances with similar activity, particularly non-steroidal anti-inflammatory drugs; - Last trimester of pregnancy and lactation (see section 4.6); - Children and adolescents with flu or chickenpox symptoms due to the risk of Reye's syndrome; - Children and teenagers under the age of 16.

Side effects

The most frequently observed side effects are affecting the gastrointestinal tract and can occur in about 4% of subjects who take acetylsalicylic acid as an analgesic-antipyretic. This percentage increases significantly in subjects at risk of gastrointestinal disorders. These disorders can be partially alleviated by taking the medicine on a full stomach. Most of the undesirable effects are dependent on both the dose and the duration of treatment. Side effects seen with acetylsalicylic acid are generally common to other NSAIDs. Blood and lymphatic system disorders Prolonged gastrointestinal bleeding time, decreased platelets (thrombocytopenia) in extremely rare cases. Following haemorrhage, acute and chronic post-haemorrhagic anemia / iron deficiency (due for example to occult micro-haemorrhages) may occur with alterations in laboratory parameters and related clinical signs and symptoms such as asthenia, pallor and hypoperfusion. Nervous system disorders Headache, dizziness. Rarely: Reye's syndrome (*) Rarely to very rarely: cerebral haemorrhage, especially in patients with uncontrolled hypertension and / or on anticoagulant therapy, which, in isolated cases, can be life threatening. Ear and labyrinth disorders Tinnitus (ringing / rustling / ringing / ringing in the ears). Respiratory, thoracic and mediastinal disorders Asthma, rhinitis, epistaxis Gastrointestinal disorders Gastrointestinal bleeding (occult), discomfort, heartburn, epigastric pain, abdominal pain, vomiting, diarrhea, nausea, gingivorrhagia. Rarely: gastrointestinal erosion and / or ulceration and / or perforation and / or haemorrhage, haematemesis (vomiting of blood or "coffee" material), melaena (emission of black faeces, picee), esophagitis. Hepatobiliary disorders Rarely: hepatotoxicity (usually mild and asymptomatic hepatocellular injury) manifested by an increase in transaminases. Skin and subcutaneous tissue disorders Angioedema and / or urticaria and / or erythema (associated with hypersensitivity reactions). Renal and urinary disorders Alteration of renal function (in the presence of conditions of impaired renal haemodynamics), urogenital bleeding. General disorders and administration site conditions Peri-operative haemorrhages, hematomas. Immune system disorders Hypersensitivity reactions Asthma, angioedema, urticaria, nausea, vomiting, abdominal pain cramps, diarrhea, erythema, rhinitis (profuse rhinorrhea), nasal congestion, conjunctivitis. Rarely: anaphylaxis. Conditions of pregnancy, puerperium and perinatal : delay in childbirth. (*) Reye's Syndrome (SdR) The SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of brain pain of varying degrees: from listlessness, drowsiness or personality changes (irritability or aggression) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture should be kept in mind: vomiting may also be absent or be replaced by diarrhea. If these symptoms arise in the days immediately following a flu (or flu-like or chickenpox or other viral infection) episode during which acetylsalicylic acid or other salicylate-containing medicinal products have been administered, medical attention should be directed immediately. the possibility of an SDR. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Italian Medicines Agency Website: www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo-fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations was increased from less than 1% to approximately 1.5%. The risk has been estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre-and-post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be administered except in strictly necessary cases. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose or duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: • cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); • renal dysfunction, which can progress to renal failure with oligo – hydroamnios; the mother and the newborn, at the end of pregnancy, to : • possible prolongation of the bleeding time, and antiplatelet effect which may occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, acetylsalicylic acid at doses> 100mg / day is contraindicated during the third trimester of pregnancy. Breastfeeding Acetylsalicylic acid 500 mg tablets is contraindicated during breastfeeding (see section 4.3).

Special warnings

Hypersensitivity reactions Acetylsalicylic acid and other NSAIDs can cause hypersensitivity reactions (including asthma attacks, rhinitis, angioedema or urticaria). The risk is greater in subjects who have already experienced a hypersensitivity reaction in the past after the use of this type of drug (see section 4.3) and in subjects who have allergic reactions to other substances (e.g. skin reactions, itching, hives) . In subjects with asthma and / or rhinitis (with or without nasal polyposis) and / or urticaria, the reactions may be more frequent and severe. In rare cases, the reactions can be very serious and potentially fatal. In the following cases, the administration of the drug requires a doctor's prescription after careful evaluation of the risk / benefit ratio; - subjects at increased risk of hypersensitivity reactions (see above) - subjects at increased risk of gastrointestinal lesions - Acetylsalicylic acid and other NSAIDs can cause serious gastrointestinal side effects (bleeding, ulcer, perforation). For this reason, these drugs should not be used by patients with peptic ulcer. It is prudent that even those who have suffered from a peptic ulcer in the past avoid using it. The risk of gastrointestinal lesions is a dose related effect, as gastrolysis is greater in subjects who use higher doses of acetylsalicylic acid. - Even subjects with a habit of drinking large quantities of alcohol are more exposed to the risk of gastrointestinal lesions (bleeding in particular) - Subjects with coagulation defects or treated with anticoagulants - In subjects suffering from coagulation defects or being treated with anticoagulants, acetylsalicylic acid and other NSAIDs can cause a severe reduction in haemostatic capacity, exposing you to the risk of bleeding. - Subjects with impaired renal, cardiac or hepatic function - Acetylsalicylic acid and other NSAIDs can cause a critical reduction in renal function and water retention; the risk is greater in subjects being treated with diuretics. This can be particularly dangerous for the elderly and for those with impaired kidney or heart or liver function. - People with asthma - Acetylsalicylic acid and other NSAIDs can cause worsening of asthma. - Geriatric age (especially over 75 years) - The risk of serious side effects is greater in people of geriatric age. - Individuals over the age of 70, especially in the presence of concomitant therapies, should use Acetylsalicylic Acid only after consulting a doctor. Medicinal products containing acetylsalicylic acid are contraindicated (see section 4.3) in children and adolescents with viral infections, especially influenza A, influenza B and chickenpox, due to the risk of Reye's Syndrome, a very rare but life-threatening disease. which requires immediate medical attention. - Subjects with hyperuricaemia / gout Acetylsalicylic acid can interfere with the elimination of uric acid: high doses have a uricosuric effect while (very) low doses can reduce its excretion. It should also be considered that acetylsalicylic acid and other NSAIDs can mask the symptoms of gout by delaying its diagnosis. An antagonistic effect with uricosuric drugs is also possible (see section 4.5): - Drug combinations not recommended or requiring special precautions or dosage adjustment. The use of acetylsalicylic acid in combination with some drugs may increase the risk of serious side effects (see section 4.5). Do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time. Fertility The use of acetylsalicylic acid like any drug that inhibits prostaglandin synthesis and cyclooxygenase may interfere with fertility; female subjects must be informed of this and in particular women who have fertility problems or who are undergoing fertility investigations. If you have to undergo surgery (even a minor one, for example the extraction of a tooth) and in the previous days you have used acetylsalicylic acid or another NSAID, you must inform the surgeon for the possible effects on coagulation . Since acetylsalicylic acid can cause gastrointestinal bleeding, it must be taken into account in case it is necessary to perform a search for occult blood. Before administering any medicine, all necessary precautions must be taken to prevent unwanted reactions; particularly important is the exclusion of other contraindications and conditions that may expose you to the risk of potentially serious side effects listed above. If in doubt consult your doctor or pharmacist.

Expiry and Retention

The package must be kept tightly closed. Store at a temperature not exceeding 25 ° C.

Active principles

Each tablet contains 500 mg of acetylsalicylic acid. For the full list of excipients see section 6.1

Excipients

Microcrystalline cellulose, corn starch, talc.